The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. DOSAGE AND ADMINISTRATION Initial U.S. Approval: 1974 1-800-678-1605, Manufactured By: 0000031965 00000 n (See PRECAUTIONS: General.) Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. . H|TMs6Wu*Q6i\l.` Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. trailer . a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) 0000001797 00000 n Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration. %PDF-1.3 % The stability of Meropenemreconstituted in solution is influenced by the following factors: Storage temperature: The drug is stable for longer time in solutions stored at 4 to 5C than in solutions stored at 21 to 26C. Cancer Chemother Pharmacol. 2.2 Recommended Dosage for Iron Deficiency Anemia Increased Risk of Toxicity in Patients with Underlying Conditions (See Special Populations under Pharmacokinetics.). ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). 0000002909 00000 n Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. Administer test dose prior to first therapeutic dose. 0000010855 00000 n 0000000016 00000 n Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. An official website of the United States government. INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02). INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. May increase risk for anaphylaxis with concomitant use, Bone scans using imaging agents labeled with technetium Tc 99m (diphosphonate), Dense, crescentic areas of activity along the contour of the iliac crest, visualized 16 days after IM administration of iron dextran, Possible reduced bone uptake, marked renal activity, and excessive blood pool and soft tissue accumulation, Therapeutic duplication; increased risk for iron toxicity, Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran, Serum ferritin concentrations peak approximately 79 days following an IV iron dextran dose and slowly return to baseline over a period of about 3 weeks, Bone marrow examination for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells, May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium, Prolonged partial thromboplastin time following IV administration of iron dextran when the blood sample for the test is mixed with anticoagulant citrate dextrose solution but not sodium citrate solution, Blood typing and cross-matching unaffected. There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. Infed should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. 0000008617 00000 n Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. Dosage (Normal Hb for Children 15 kg or less is 12 g/dl). PMC Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. II. The maximum daily dose of INFeD should not exceed 2 mL. INFeD (iron dextran injection), for intravenous or . Do Not Copy, Distribute or otherwise Disseminate without express permission. endstream endobj 57 0 obj<> endobj 58 0 obj<>stream 0000003347 00000 n Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. For all medical inquiries contact: Unable to load your collection due to an error, Unable to load your delegates due to an error. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. If there is no reaction after 1 hour continue. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. *Qp"Q!J Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. Each monograph contains stability data, administration guidelines, and methods of preparation. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability of frozen antibiotics. 0000036781 00000 n Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Based on: Desired Hb = the target Hb in g/dl. rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Dilution not recommended by manufacturers, but there have been reports of the total calculated dose of iron dextran being diluted in 2501000 mL of 0.9% sodium chloride injection for IV infusion [off-label]. This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet, For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet. 8.2 Lactation Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. 1972;9:94-98. Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. 0000002986 00000 n 4. startxref Protect from light. Systemic exposure to iron dextran may be increased. Allergan Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. (See Sensitivity Testing under Dosage and Administration.) Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Curr Opin Clin Nutr Metab Care. Clinical Considerations Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. FOIA 0000001877 00000 n Brand names: Dexferrum, INFeD HHS Vulnerability Disclosure, Help Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Before HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> 16.2 Stability and Storage The pH of the solution is between 4.5 to 7.0. 0000040000 00000 n . Do not administer Infed to patients with evidence of iron overload. Copyright 1993-2021 Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. N}F( 9N(i{:%NISD;%NIS*T1 Bookshelf Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. It is not known if INFeD is safe and effective in children younger than 4 months of age. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. To calculate a patient's weight in kg when lbs are known: Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. II. 12.2 Pharmacodynamics Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. An official website of the United States government. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv 0000012149 00000 n Accessibility 0000005561 00000 n Accessibility Take precautions to be prepared to treat potential allergic reactions. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. ],kI#tp. . Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. The etiology of these reactions is not known. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. (5.1) If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 0000010877 00000 n 0000026302 00000 n Anemia Associated with Chronic Renal Failure. endobj Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including Infed. 16.1 How Supplied Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, 8600 Rockville Pike Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. <> . 5. Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents).
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